RECRUITING

Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial. Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, retention rates, selection of most appropriate outcome measures, provide sample size estimates for a larger trial, increase the researchers\' experience with the study intervention. A complete list of objectives and aims are listed under "Objectives". This study hopes to treat 12-24 neonates using 650nm light of irradiance 10mW/cm2 for 5 minutes twice a day each day for 12 days. We will also call the parents at 6 months and 12 months to track developmental milestones.

Official Title

Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

Quick Facts

Study Start:2024-11-25
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06797219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Days to 1 Month
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * neonates with intraventricular hemorrhage grade 3 or 4 less than 1 month old.
  1. * neonates without IVH grade 3/4 or older than 1 month.

Contacts and Locations

Study Contact

Garrett Gianneschi, Medical
CONTACT
908-294-1161
garrettgianneschi@gmail.com
Onajovwe Fofah, Medical
CONTACT
973-972-6753
fofahon@njms.rutgers.edu

Principal Investigator

Onajovwe Fofah, Medical
PRINCIPAL_INVESTIGATOR
Rutgers, The State University of New Jersey

Study Locations (Sites)

Rutgers - New Jersey Medical School / University Hospital
Newark, New Jersey, 07103
United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Onajovwe Fofah, Medical, PRINCIPAL_INVESTIGATOR, Rutgers, The State University of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-25
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2024-11-25
Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

  • low level laser therapy
  • neonate
  • developmental milestones
  • intraventricular hemorrhage

Additional Relevant MeSH Terms

  • Intraventricular Hemorrhage of Prematurity
  • Hydrocephalus